Stability chambers installation qualification

It is essential that an environmental chamber be qualified at its intended range of use prior to commissioning for routine operation in a stability program. A qualification protocol should be prepared describing the qualification procedures and must include predefined acceptance criteria for successful qualification. The qualification consists of three components an installation qualification, operation qualification, and performance qualification. 

As with most pieces of equipment used in a GMP operation, stability chambers must go through a qualification process prior to use. This process traditionally includes three stages identified as the Installation Qualification (IQ), Operation Qualification (OQ), and Performance Qualification (PQ). At each stage a qualification protocol is written, approved, and executed. After successful execution a qualification report is written and approved. Upon approval, the next qualification stage is performed. Many components of equipment qualification are common to all pieces of equipment. A brief definition of each stage of qualification will be provided along with what might be included that is unique to stability chambers. 

Chambers used in the formal stability program must go through qualification and calibration procedures. The chambers should be qualified at the time of purchase to assure a proper installation, a process denoted installation qualification (IQ). This procedure documents that the chamber has been installed properly and that it meets the manufacturer s specifications. The chamber should also be... 

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